ISO 13485 Certification & Auditing

Develop a quality management system focused on trust

The update to ISO 13485:2003, the internationally recognized quality management systems standard for the medical device industry, with over 27,000 certificates globally, was published on February 25, 2016. For more information about the changes, see our ISO 13485:2016 fact sheet (.PDF).

The medical device business is grounded in trust. Before a device is used on a patient, it must first win the trust of many stakeholders. From medical staff, hospitals, and healthcare institutions to regulators and often the public themselves.

A quality management system is integral to this chain of trust. It ensures that your medical products consistently meet customer expectations of quality, safety, and performance.

An ISO 13485 certification can allow your organization to:

• Improve your process quality and transparency
• Ensure quality, safety and performance of your devices
• Raise brand reputation and consumer trust and satisfaction
• Avoid costly product recalls by delivering consistent quality and safety

Our Services to Help You Achieve 13485 Certification

Achieving ISO 13485 certification proves that your medical devices have been manufactured under a certified quality management system. Our auditors have an established history of assessing leading medical device manufacturers with ISO 13485 audits and certification. We know how to assess your operational efficiency. 

• ISO 13485 Quality Management System – Medical Device Certification
• ISO 9001 Quality Management System – General
• ISO 14001 Environmental Management
• Medical Device Directive 93/42/EEC (MDD)
• In Vitro Diagnostic Directive 98/79/EC (IVDD)
• Active Implantable Medical Devices Directive 90/385/EEC (AIMD)
• Japan GMP and Quality Regulation (JGMP)
• Facility Inspection for NRTL, GS-Mark, etc.
• Good Dialysis Practice- quality and application rules standard for dialysis clinics